Contact us:
ℹ️ InnoVigilance Pharma Inc.
📍 404, 15e rue, Laval, Quebec, H7N 1L6, Canada
📧 [email protected]
Land the Drug Safety position YOU are passionate about
We know the struggle to get a foot in the door of the huge pharmaceutical industry; that’s why we have tailored this certificate pathway to be exactly as the industry demands and enter any interview with full confidence!
Course in numbers
What to expect?
Self Paced Training
0
/7
Online Lectures
0
Membership to ASP
0
Year
Handouts and Guidelines
0
Quizzes
0
CV update and Interview Coaching
Overview
Why should you be a Qualified Professional in Drug Safety QPDS?
The average salary of a Drug Safety Physician is about $144K/year! and the pharmacovigilance market is going to grow to $13 billion in 2027! that means increasing demand across the world for skilled professionals who can carry out surveillance safety trials and make reliable reports by leveraging the technological advancements in the field.
Objective
know the most critical aspects affecting Pharmacovigilance employees firsthand
The course will be delivered by experienced trainers in the field who know the most critical aspects affecting PV employees firsthand. Throughout the training sessions, practical examples and frequently asked questions will be addressed through a rigorous and practical approach.
International
Our course will treat another different subject such as the international context of pharmacovigilance, and sources of information in pharmacovigilance, in order to document signal detection, ICSRs, PSURs, referrals and more, presenting practical situations which may impact on daily activities.
Uptodate
We will also be talking about the latest updates national and international guidance (ICH, FDA, EMA, Health Canada, PMDA) for signal detection in pharmacovigilance, with practical examples of medical evaluation in signal management, focusing also on the issues most frequently encountered.
Recommendations
When you become Qualified Professional in Pharmacovigilance and Drug Safety (QPDS) you will get one year membership to:
This certificate is presented to you by
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Target Audience
This Certification is Designed for Graduates Who have a Scientific Background
Pharmacists
BSc. in pharmacy, PharmD, MSc in pharmacy, PhD in pharmacy.
Medical Practitioners
Medical doctors, and nurses.
Scientists & Researchers
Medical doctors, and nurses.
Opportunities
This Certification is Designed for Professionals Aspiring to Make a Career as
Drug safety, PV scientist, specialist, associate
Medical Safety scientist, specialist, reviewer
Clinical trial case processing safety specialist
Risk management, assessment, minimization manager, director etc.
PV safety and analytics reporting analyst, specialist, associate
Data management, governance, operations manager, associate etc.
Learning Outcomes
North America
- Learning based on the FDA and Health Canada, ICH Guidelines and regulation on Good Pharmacovigilance Practices (GVP) to leverage compliance.
- Develop expertise on how Pharmacovigilance is involved from Clinical Research to Post-marketing.
- Understand different roles and responsibilities in Pharmacovigilance departments.
- Practice Pharmacovigilance activities (case processing, periodic reports, risk management…).
- Manage Quality Control, reconciliation Performance and Compliance.
- Safety database training.
- Soft Skills development.
- Learn about Audit and inspections in Pharmacovigilance.
Learning Outcomes
Europe
- Learning based on the EMA, ICH Guidelines and regulation on Good Pharmacovigilance Practices (GVP) to leverage compliance.
- Develop expertise on how Pharmacovigilance is involved from Clinical Research to Post-marketing.
- Understand different roles and responsibilities in Pharmacovigilance departments.
- Practice Pharmacovigilance activities (case processing, periodic reports, risk management…)
- Manage Quality Control, reconciliation Performance and Compliance.
- Safety database training.
- Soft Skills development.
- Learn about Audit and inspections in Pharmacovigilance.
Success Story
International Medical Doctor to Pharmacovigilance Specialist at McKesson
When I moved to Canada I was a freshly graduated medical doctor without any experience in the pharmaceutical industry and some experience in the clinical research field. I started seeking for an interesting job in the medical area giving that it is very difficult to have equivalency of my medical diploma. It was a long journey! I applied for clinical research entry level jobs, I had interviews but without success! I followed a pharmacovigilance course given by InnoVigilance which permitted to me to discover the PV world, and to have the precious key which allowed me to have an interview at McKesson for the position of pharmacovigilance specialist. I am really grateful to them.
Learning Path
Qualified Professional in Pharmacovigilance and Drug Safety (QPDS)
Module 0
Basics
Pharmacovigilance Introduction and Basics
Overview of drug safety and pharmacovigilance basic notions, terminology, regulation and main pharmacovigilance activities.
Module 1
Regulations
Drug Safety Regulation and Good Pharmacovigilance Practices
As Drug safety is a highly regulated field, in this module, the pharmacovigilance trainee will acquire a strong knowledge and a deep understanding of both local and global regulation and good pharmacovigilance practices which are the key to reach compliance and face challenges during audits and inspections.
Module 2
Operations
Pharmacovigilance and Drug Safety Operations
In this module, the Pharmacovigilance trainee will be able to handle basic steps in drug safety as day to day activities (Data collection, Data Entry in Safety database, Coding of adverse reaction descriptions, Case causality assessment and Timely reporting to authorities).
Module 3
Safety and Quality
Safety Medical Writing, Quality and Compliance
Once the pharmacovigilance trainee understands drug safety regulation and is able to handle PV activities on a daily basis, this module, allow him/her to lead projects on redacting Aggregate Reports and Risk Management Plans, identifying new potential risks and developing risk minimization measures, ensuring Quality and Compliance and contributing in Audits and Inspections.
QPDS
Job Ready
Qualified Professional in Pharmacovigilance and Drug Safety
Get ready for the pharmaceutical industry with this complete suite that will give you access to all 4 modules mentioned above plus CV updates and job readiness, interview mock, and personal coaching for a lesser price!
About the instructor
Who is Dr. Omar Aimer?
Present
North America and Europe
Speaker & Chair of roundtables
World Congress Americas & Europe
Let's e-meet!
Do you have questions and concerns about the certificate?
I'm available for consultations!
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